To validate the results from two RCTs that SCS is indeed capable of treating otherwise refractory diabetic neuropathic pain, and to evaluate the effects of burst stimulation settings in this patient group.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure is the change in neuropathic pain as measured by VAS
score after 6 months of SCS.
Secondary outcome
Secondary objectives are an evaluation of the efficacy of SCS treatment in
patients with diabetic neuropathic pain as measured by change in pain intensity
at all visits, and an evaluation of following health outcome measures: McGill
Pain Questionnaire, EuroQoL 5D, HADS, PVAQ, changes in pain medication,
patient*s satisfaction and stimulation preference.
Background summary
Two Randomised Clinical Trials have shown that in many patients refractory
painful diabetic neuropathy can be treated effectively with Spinal Cord
Stimulation (SCS). It has also been suggested that novel stimulation settings
might be even more effective in this patient population than the standard tonic
stimulation settings that have been used in the two RCTs. In several countries
diabetic neuropathy has now become a reimbursed indication for SCS. A
validation study to confirm the effects of SCS in diabetic neuropathic pain
will be relevant.
Study objective
To validate the results from two RCTs that SCS is indeed capable of treating
otherwise refractory diabetic neuropathic pain, and to evaluate the effects of
burst stimulation settings in this patient group.
Study design
The study is an open, prospective, validation study consisting of:
- A pre-study screening period during which patients will be evaluated for
study eligibility.
- Trial stimulation and surgical implantation of the SCS system.
- During the first 12 weeks, SCS settings are adjusted and evaluated by the
patients. Settings include 3 weeks of tonic, high burst, low burst stimulation
settings and SCS off, in random order.
- Evaluation visits (to acquire pain scores and other health outcome measures)
will occur at 3, 6, 9 and 12 weeks, and 6 months after implantation.
- After completion of the 6 months study treatment period, all patients will be
followed in accordance with standard medical care.
Intervention
All patients will have a trial stimulation period with an external SCS pulse
generator. If the trial is successful ( > 25% pain reduction) an SCS system
will be implanted.
Study burden and risks
Implantation of a spinal cord stimulator is a standard and common procedure in
Medische Spectrum Twente. The risks of the procedure are similar to other small
surgical procedures,
Koningsplein 1
Enschede 7512 KZ
NL
Koningsplein 1
Enschede 7512 KZ
NL
Listed location countries
Age
Inclusion criteria
- Peripheral neuropathic pain that exists for more than 6 months and is due to diabetes mellitus.
- Patient cannot be treated further otherwise according to patients* medical specialist.
- The pain-sensation on a visual analogue scale is 5 or more.
Exclusion criteria
- Age < 18 years.
- Psychological problems that requires treatment.
- Addiction (i.e. compulsory) to: drugs, alcohol, medication.
- Insufficient cooperation by patient (motivation, insight or communication).
- Coagulation irregularities/ Anti-coagulants.
- Immune compromised.
- Life expectancy less than 1 year.
- Pregnancy.
- Local infection at the site of the incision
- Implanted pacemaker, ICD or other neuromodulation system
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60465.044.17 |